The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Spectra Indirect Ophthalmoscope.
| Device ID | K970029 |
| 510k Number | K970029 |
| Device Name: | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene R Van Arsdale |
| Correspondent | Eugene R Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272711807 | K970029 | 000 |
| 05055272711791 | K970029 | 000 |
| 05055272711715 | K970029 | 000 |